This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.
Abstract Details
Activity Number:
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566
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 4, 2010 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract - #307128 |
Title:
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Some Diagnostic Issues in Cardiovascular Device Studies
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Author(s):
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Shanti Gomatam*+
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Companies:
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FDA/CDRH
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Address:
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10903 New Hampshire Avenue , Silver Spring, MD, 20993-0002,
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Keywords:
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Monitoring devices
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Abstract:
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The design of studies and the assessment of diagnostic performance have particular challenges in some classes of cardiovascular devices. Some specific examples are: monitoring devices that are intended to alert one of some impending cardiovascular event; devices where an in vivo reference standard measurement is not possible; and devices used for intravascular imaging. This work presents these challenges and discusses approaches to dealing with them.
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The address information is for the authors that have a + after their name.
Authors who are presenting talks have a * after their name.
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